MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-24 for ALIMED 920261 * manufactured by Alimed Corp..
[18610838]
Shield checked using geiger meter, which indicated presence of radiation source. Shipped july 16, 1997. Received in mail monday 7-21-97.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011770 |
| MDR Report Key | 107876 |
| Date Received | 1997-07-24 |
| Date Added to Maude | 1997-07-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALIMED |
| Generic Name | THYROID SHIELD |
| Product Code | KPY |
| Date Received | 1997-07-24 |
| Model Number | 920261 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | PO#97-53580 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 106026 |
| Manufacturer | ALIMED CORP. |
| Manufacturer Address | 297 HIGH ST. DEDHAM MA 02026 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-07-24 |